Genomic Profile Can Improve Confidence in Active Surveillance of Prostate Cancer

MedicalResearch.com Interview with:

Bela S. Denes, MD, FACS Senior Director Medical Affairs UROLOGY Genomic Health Inc. Redwood City, CA. 94063

Dr. Bela S. Denes

Bela S. Denes, MD, FACS
Senior Director Medical Affairs
UROLOGY
Genomic Health Inc.
Redwood City, CA. 94063

MedicalResearch.com: What is the background for this study?

Response: This is a prospective community based non-interventional study designed to provide information on the utility of Oncotype GPS in the management of men presenting with a new diagnosis of clinically localized low risk prostate cancer. We sought to understand the impact of incorporating a molecular marker into the shared treatment decision in practices already well versed in Active Surveillance (AS) as measured by persistence on surveillance at 2 years as well as a number of patient reported outcomes. The current publication reports on the results of a one year pre-specified interim analysis.

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Malignancies More Common In Men With BRCA Germline Mutations

MedicalResearch.com Interview with:
Roy Mano, MD and
David Margel, MD, PhD
Department of Urology, Rabin Medical Center
Petach Tikva, Israel

MedicalResearch.com: What is the background for this study?

Response: According to previous reports, male BRCA mutation carriers have a higher risk of developing malignancies of the prostate, pancreas, breast, colon and melanoma. While malignancy screening protocols for female BRCA carriers are well established and widely implemented, little is known about the optimal screening protocol for male BRCA carriers, and current screening protocols focus on malignancies of the breast and prostate rather than offer a comprehensive screening protocol for all BRCA associated malignancies.

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Minimally Invasive Rezum® Radiofrequency System Treats Obese Men With Lower Urinary Tract Symptoms Caused by BPH


MedicalResearch.com Interview with:
Dr. Nikhil K. Gupta
and
Kevin McVary, MD, FACS
Professor, Department of Surgery
Chair, Division of Urology
Southern Illinois University School of Medicine

MedicalResearch.com: What is the background for this study?

Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms.

Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms.

Response: Male lower urinary tract symptoms due to benign prostatic hyperplasia, or LUTS due to BPH, have most commonly been treated with a combination of medication, such as alpha-blockers and 5-alpha reductase inhibitors, and surgery, such as transurethral resection of prostate (TURP) and Greenlight photovaporization of prostate (PVP). These treatments, however, have potentially serious adverse and sexual side effects. Minimally invasive surgical therapies (MIST) for LUTS due to BPH have tried to thread the needle between medications and invasive surgery, giving effective relief of symptoms with minimal anesthetic need while preserving sexual function. Previously developed MISTs have been unable to provide durable relief of symptoms, causing patients to undergo multiple treatments in a short period of time, and have been limited by prostate size and conformation, e.g. the inability to treat a middle lobe or median bar. LUTS due to BPH is also very strongly and likely causally linked with obesity, and obesity seems to have an effect on the efficacy of treatment as well, as obesity affects response to medication and tends to dampen the treatment effect of TURP.

Convective Radiofrequency Water Vapor Energy ablation of the prostate, named Rezūm®, is a new MIST that uses radiofrequency to generate energy in the form of water vapor. The water vapor acts as a convective energy source and, once injected into the treatment area, distributes itself evenly within the treated tissue, causing uniform necrosis througout the treated area. This mechanism using convection is in contrast to previous technologies using conductive heat energy, which created a heat gradient with tissue closest to the heat source receiving the largest amount of energy and tissue farthest from the heat source receiving almost no energy. Thus conductive energy has a different effect on different parts of the treated area. With Rezūm, MRI studies have shown that the water vapor creates a uniform treatment effect while staying within collagen barriers, obeying natural tissue planes and affecting only the intended treatment areas.

The purpose of this study was to determine the efficacy of Rezūm in treatment of LUTS due to BPH, examine the treatment’s effect on sexual function, and to determine whether obesity affected treatment efficacy.

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Flibanserin- Addyi -Improved Sexual Health in Women With Hypoactive Sexual Desire Disorder

MedicalResearch.com Interview with:

Dr. Michael Krychman, MD Executive Director: The Southern California Center for Sexual Health and Survivorship, Medical Director: Sexual Medicine at Hoag Hospital Newport Beach CA Clinical faculty member University of Southern California Los Angeles, CA

Dr. Krychman

Dr. Michael Krychman, MD
Executive Director: The Southern California Center for Sexual Health and Survivorship,
Medical Director: Sexual Medicine at Hoag Hospital Newport Beach CA
Clinical faculty member
University of Southern California
Los Angeles, CA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This post hoc analysis pooled data from three 24-week, double-blind, placebo-controlled studies (VIOLET, DAISY, and BEGONIA) of flibanserin in premenopausal women with acquired, generalized HSDD5-7. Patients who received flibanserin 100 mg once daily at bedtime (qhs) or placebo were included in the analysis. The Female Sexual Function Index (FSFI) consists of 19 items across 6 domains. Scores range from 2 to 36. Higher scores indicate better sexual functioning. Scores under 26 indicate sexual dysfunction. Analysis of covariance was used to evaluate changes from the first week to week 24 in the FSFI domain and total scores were compared for flibanserin 100 mg qhs versus placebo. For patients who discontinued study participation prior to week 24, the last postbaseline observation was carried forward (LOCF).

Results found that treatment with flibanserin 100 mg qhs produced statistically significant improvement, relative to placebo, on all domains of the FSFI (desire, arousal, lubrication, orgasm, satisfaction and pain) in premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

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Active Surveillance Can Be Expanded To Select Group of Younger Men With Prostate Cancer

MedicalResearch.com Interview with:

Keyan Salari, MD, PhD Resident in Urologic Surgery Keyan Salari is currently completing his residency in the Harvard Program in Urologic Surgery at the Massachusetts General Hospital, and is conducting post-doctoral research in cancer genomics in the Garraway Lab at the Dana-Farber Cancer Institute and the Broad Institute of Harvard and MI

Dr. Keyan Salari

Keyan Salari, MD, PhD
Resident in Urologic Surgery
Keyan Salari is currently completing his residency in the Harvard Program in Urologic Surgery at the Massachusetts General Hospital, and is conducting post-doctoral research in cancer genomics in the
Garraway Lab at the Dana-Farber Cancer Institute
and the Broad Institute of Harvard and MIT

MedicalResearch.com: What is the background for this study?

Response: Active surveillance is an effective strategy addressing the problem of over treatment of clinically indolent prostate cancer, but data on the role of active surveillance in younger men is limited. Younger men diagnosed with prostate cancer are typically counseled to undergo treatment as opposed to surveillance of their prostate cancer.

To potentially expand the role of active surveillance to younger patient populations, we undertook this study evaluating the outcomes of younger men under 60 years of age who elected to pursue active surveillance of their prostate cancer.

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